Question · Q4 2025
Jiwon Kim, on behalf of Yigal Nochomovitz, asked about the Lung Clearance Index (LCI) assessment in the phase Ib CF study, what was observed, the expected level of improvement in phase IIb, and if the FDA reviewed the phase Ib LCI data.
Answer
Joseph Payne, President and CEO, confirmed LCI was assessed in phase Ib for safety/tolerability. Alan H. Cohen, Chief Medical Officer, noted challenges with small numbers in early studies but highlighted that the current 12-week study benefits from prior experience, CF Foundation support (natural history study for comparator), and improved LCI technologies. He expects the larger, longer study to provide more robust and interpretable data, correlating LCI improvements with HRCT mucus plug burden.
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